Rectal Cancer, Adenocarcinoma Clinical Trial
Official title:
A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.
At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy
(NCRT) followed by radical surgery has become the standard of care for the locally advanced
mid/low rectal cancer, having been proved to substantially improve the local control of the
disease, whereas not being able to improve the long-term survival. According to present
clinical practice guidelines, all patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal
cancer are recommended to undergo the preoperative long-term radiotherapy with concurrent
5FU based chemotherapy, followed by the radical resection of the tumor. After surgery,
adjuvant chemotherapy (ACT) is recommended for all these patients without considering the
postoperative pathological results. Recently, however, some authors proposed that different
strategy of combined modality therapy should be applied in different patients according to
their risk of relapse, instead of using the uniform NCRT strategy. In this research, on the
basis of investigator's previous clinical practice and researches, investigators plan to
stratify the patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer into several
subgroups according to tumor stages and the risk of relapse. Different therapeutic strategy
will be applied in different groups, at the aim of improving the overall therapeutic
effects, as well as reducing the treatment adverse effects.
This research consists of four trials.
Trial A: A multicenter, prospective, randomized trial to compare neoadjuvant
chemoradiotherapy (NCRT) followed by radical surgery with surgery alone for cT3a-bN0-1aM0
mid rectal cancer.
Research objects: Patients with locally advanced rectal cancer, being clinically staged
T3a-bN0-1aM0 by rectal MRI and/or endorectal ultrasonography (ERUS), the tumor being located
6-12 cm above the anal verge.
After giving fully informed consent, the prospective participants will be randomly divided
into two groups, receiving the following two treatment modalities.
Group A1: radical surgery + adjuvant chemotherapy (ACT) Group A2: NCRT + radical surgery +
ACT
Trial B: A multicenter, prospective, randomized trial to compare combined versus
single-agent chemotherapy with concurrent radiotherapy for cT4NanyM0 or cTanyN2M0 rectal
cancer.
Research objects: Patients with locally advanced rectal cancer, being clinically staged
cT4NanyM0 or cTanyN2M0 by rectal MRI and/or ERUS, or patients with any other risk factors
for tumor relapse.
After giving fully informed consent, the prospective participants will be randomly divided
into two groups, receiving the following two treatment modalities.
Group A1: NCRT with combined chemotherapy (Capox regimen) + radical surgery + ACT Group A2:
NCRT with single-agent chemotherapy (Capecitabine) + radical surgery + ACT
Trial C: A multicenter, prospective, randomized trial to compare transanal ndoscopic
microsurgery (TEM) excision versus radical resection of rectal cancer being staged clinical
complete response (cCR) after NCRT.
Research objects: Patients with locally advanced rectal cancer, being clinically staged cCR
after NCRT.
After giving fully informed consent, the prospective participants will be randomly divided
into two groups, receiving the following two treatment modalities.
Group A1: TEM excision + ACT Group A2: radical surgery + ACT
Trial D: A prospective, observational study to determine the value of circulating tumor DNA
(ctDNA) for predicting the therapeutic effects of NCRT for locally advanced rectal cancer
and the patients' long-term prognosis.
Research objects: Patients with locally advanced mid/low rectal cancer (cT3-4N0M0 or
cTanyN+M0) who undergo NCRT.
After giving fully informed consent, the prospective participants will undergo the classical
'NCRT + radical surgery + ACT' comprehensive treatment. Serial analysis of ctDNA will be
performed at specific time points including pre-NCRT, post-NCRT, postoperative week 1,
post-ACT, postoperative year 1, 2, and 3. The next-generation sequencing of surgical
specimens will be performed as well. Participants will be observed and examined during the
entire course of treatment and the follow-up period. The pathological results of the
surgical specimen and the 3 year disease free survival (3y-DFS) will be the main end-points.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05495308 -
"Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and Pathologic Complete Response After Neoadjuvant Treatment. Results From an Observational Retrospective Multicenter Long-term Follow-up Study".
|
||
| Terminated |
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Phase 2 | |
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