Total Neoadjuvant Therapy in Rectal Cancer Treatment

Rectal Cancer Clinical Trial

Official title:

Total Neoadjuvant Therapy in Rectal Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747951
• Other study ID #: 127872
• Status: Recruiting
• Phase: Phase 4
• Start date: October 30, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: February 2021
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: Sergey Sychev, Dr.Med.Sc
• Phone: +7 9097845436
• Email: dr.sychev.si[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

Description:

In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: November 1, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have signed an approved informed consent form for the stud;

• Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (??2-T4N1-2M0);

Exclusion Criteria:

• rectal cancer recurrence;

• Primary-multiple tumours of other localizations;

• pelvis radiotherapy in anamnesis;

• pregnancy, breastfeeding;

• distant metastasis;

• ECOG score 3-4

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Combination Product:
• Concurrent Chemoradiotherapy
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d

Procedure:
• TME
Total mesorectal excision

Drug:
• consolidation chemotherapy
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course
• adjuvant chemotherapy
Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23. Review. — View Citation

Rödel C, Martus P, Papadoupolos T, Füzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. Epub 2005 Oct 24. — View Citation

Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, Melis M. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012 Sep;19(9):2822-32. doi: 10.1245/s10434-011-2209-y. Epub 2012 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of complete responses	The rate of pathological or clinical complete responses	3-6 months
Secondary	Rate of R0-resections	Rate of R0-resections	immediately after surgery
Secondary	Rate of compliance with radiotherapy and chemotherapy	Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)	6-8 months
Secondary	rate of intraoperative and postoperative complications	Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification	0-30 days after surgery