Total Neoadjuvant Therapy in Rectal Cancer Treatment

NCT04747951 | Unknown Phase 4 FDA Drug

• 1 other identifier: 127872
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer

Keywords

rectal cancer; total neoadjuvant therapy; colorectal disease

Outcome Measures

Primary Outcomes (1)

• The rate of complete responses

  The rate of pathological or clinical complete responses

  3-6 months

Secondary Outcomes (3)

• Rate of R0-resections

  immediately after surgery

• Rate of compliance with radiotherapy and chemotherapy

  6-8 months

• rate of intraoperative and postoperative complications

  0-30 days after surgery

Study Arms (2)

total neoadjuvant therapy

EXPERIMENTAL

Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.

Combination Product: Concurrent Chemoradiotherapy; Procedure: TME; Drug: consolidation chemotherapy; Drug: adjuvant chemotherapy

standard therapy

ACTIVE COMPARATOR

Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

Combination Product: Concurrent Chemoradiotherapy; Procedure: TME; Drug: adjuvant chemotherapy

Interventions

Concurrent Chemoradiotherapy COMBINATION_PRODUCT

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

Also known as: Radiotherapy

standard therapy; total neoadjuvant therapy

TME PROCEDURE

Total mesorectal excision

standard therapy; total neoadjuvant therapy

consolidation chemotherapy DRUG

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

Also known as: XELOX, CAPOX

total neoadjuvant therapy

adjuvant chemotherapy DRUG

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

Also known as: mFOLFOX

standard therapy; total neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have signed an approved informed consent form for the stud;
• Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);

You may not qualify if:

• rectal cancer recurrence;
• Primary-multiple tumours of other localizations;
• pelvis radiotherapy in anamnesis;
• pregnancy, breastfeeding;
• distant metastasis;
• ECOG score 3-4

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead

Study Sites (1)

State Scientific Centre of Coloproctology

Moscow, 123453, Russia

RECRUITING

Related 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.

  PMID: 22362002 BACKGROUND

• 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.

  PMID: 22434243 BACKGROUND

• Rodel C, Martus P, Papadoupolos T, Fuzesi 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. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24.

  PMID: 16246976 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemoradiotherapy; Radiotherapy; Consolidation Chemotherapy; XELOX; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Evgeny Rybakov, Dr.Med.Sc

  Head of Surgical department of oncoproctology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey Sychev, Dr.Med.Sc

CONTACT

+7 9097845436; dr.sychev.si@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgical department of oncoproctology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: October 30, 2020
• Primary Completion: October 30, 2023
• Study Completion: November 1, 2023
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)