Chemoradiotherapy Clinical Trial
— TNTCRTOfficial title:
Total Neoadjuvant Treatment Versus Conventional Neo-chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk Factors: a Multicenter Randomized Phase III Clinical Study.
NCT number | NCT03177382 |
Other study ID # | TNT-2 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 15, 2017 |
Est. completion date | May 30, 2023 |
Verified date | May 2018 |
Source | West China Hospital |
Contact | Ziqiang Wang |
Phone | +86 28 85422480 |
wangzqzyh[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Purpose:To compare the efficacy and the safety of total neoadjuvant chemotherapy + TME with
standard neoadjuvant concurrent chemoradiotherapy + TME + adjuvant chemotherapy for locally
advanced rectal cancer patients with high risk factors of recurrence.
Evaluation indexes: (1) the primary evaluation index: disease-free survival (disease free
survival, DFS); (2) the secondary evaluation indexes: pathological complete remission rate
(pCR), the 3 year overall survival (overall survival, OS); R0 dissection rate; distant
metastasis free survival (DMFS); local recurrence free survival rate (LRRFS); tumor
regression grade (TRG, tumor regression grade) and the adverse reaction rate during the
chemotherapy, the operation safety index; quality of life; psychological and cognitive
effects, assessment of nutritional status.
Safety evaluation indexes: including all adverse events observed during the experiment.
Number of patients: 458 cases Study design: patients will be randomly assigned into the total
neoadjuvant treatment group (experimental group, TNT) and neoadjuvant concurrent chemotherapy
group (control group, CRT) in the ratio of 1: 1. The patients of experimental group will be
given 1 cycle of induction CAPOX (Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2, bid,
d1-14) prior to radiotherapy. Then pelvic IMRT/VMAT (50-50.4Gy/25-28f) and two cycles of
concurrent chemotherapy (Oxaliplatin 130mg/m2, d1, d 22, Capecitabine 825mg/m2, bid, 5d/w,
25-28d) are performed. And three cycles of consolidation chemotherapy (CAPOX) are delivered
after concurrent chemoradiotherapy. Total mesorectal excision (TME) is performed after
completion of the whole neoadjuvant treatment. The patients of control group will receive
standard concurrent neoadjuvant chemoradiotherapy with capecitabine (825mg/m2, bid, 5d/w)
followed by TME 6-8 weeks after the end of concurrent chemoradiotherapy. Then, patients are
treated with another 6 cycles of CAPOX.
Schedule: Investigators plan to finish the study in 4 years and write the related work within
2 years after the completion of this study.
Status | Recruiting |
Enrollment | 458 |
Est. completion date | May 30, 2023 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria:(1)Age: 18 ~ 70 years old; sex is not limited. (2)Patients with stage
II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one
risk factor: cT4a-b(resectable);cT3c-d with EMVI+ (Extramural venous invasion);cN2;MRF+
(MRI in evaluating the mesorectal fascia).(According to the 2010 AJCC cancer staging
system, the seventh edition). The preoperative T stage is referred to endoscopic
ultrasonography or rectal MRI. The N stage is referred to abdominal CT. The M stage is
referred to abdominal and thoracic CT. If symptoms occur, other appropriate imaging
examinations are needed(cranial MRI or ECT). (3)The lower edge of lesion is less than 12cm from anal verge according to rigid sigmoidoscopy or rectal digital examination. (4)No distant metastasis after a thorough examination . (5)Pathological diagnosis of rectal adenocarcinoma. (6)ECOG score: 0-1. (7)Patients with primary rectal cancer who had not received surgery prior to surgery (except for palliative ileostomy or colostomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy. (8)The main organ function is normal, including the following characteristics: - Blood routine examination: HB =9g/dL, WBC = 3.5/4.0×109/L,PLT= 100×109/L - Biochemical examination:Crea and BIL = 1.0 upper normal limit(ULN),ALT and AST= 2.5 upper normal limit(ULN). (9)Not allergic to 5-Fu or Platinum. (10)The site of radiotherapy had not previously received radiation. (11)If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF (Informed Consent Form) is signed until 8 weeks after the last dose of study drug. (12)Participants are volunteered to participate in this study, sign informed consent, good compliance, cooperation with follow-up. Exclusion Criteria:(1)Have had prior or concurrent cancer distinct in primary site or histology EXCEPT for curatively treated cervical cancer in situ, Basal cell carcinoma of skin. (2)Pregnant or lactating women. (3)Patients with severe cardiovascular disease and poorly controlled diabetes. (4)Mental disorder. (5)Severe infection. (6)Patients who can't finish MRI examination. (7)Patients were treated with thrombolytic therapy and anticoagulant therapy, either with bleeding diathesis or coagulopathy, or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year. (8)The past history of kidney disease, urine or urine protein found in clinical renal abnormalities. (9)The digestive tract fistula, perforation or serious ulcer disease. (10)Be allergic to 5-Fu or Platinum. (11)The presence of severe gastrointestinal diseases that affecting the absorption of oral chemotherapy drugs. (12)Additional clinical trials were attended within 4 weeks before treatment initiation. |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital | Chengdu | Sichuan |
China | The Second Affiliated Hospital of Zhejiang University | Hanzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease free survival | Time from the completion of the treatment to any recurrences or distant metastases | 3 years | |
Secondary | pathological complete remission rate | The rate of complete remission patients to all resected patients | 1 months | |
Secondary | the 3 year overall survival rate | The rate of patients alive 3 years after the completion of treatment | 3 years | |
Secondary | R0 dissection rate | The rate of patients who received R0 dissection to all the patients | 1 months | |
Secondary | distant metastasis free survival | Time from the completion of the treatment to any distant metastases | 3 years | |
Secondary | local recurrence free survival rate | The rate of patients without local recurrence to all the patients | 3 years | |
Secondary | tumor regression grade (TRG) | The level of tumor regression under pathological examination | 1 months | |
Secondary | the adverse effects during the chemotherapy | Any side effects during the chemotherapy | 3 months | |
Secondary | the operation safety index | The safety index of operation | 3 months | |
Secondary | quality of life | Patients' subjective feeling of life | 3 years | |
Secondary | psychological and cognitive effects | The psychological and cognitive changes of patients after treatment | 3 years | |
Secondary | assessment of nutritional status | The nutritional status of patients | 6 months |
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