CONVERT: Neoadjuvant Chemotherapy Alone Versus Preoperative Chemoradiation for Locally Advanced Rectal Cancer Patients

NCT02288195 | Unknown Phase 3

• 1 other identifier: NCT02288195
• Study Type: interventional
• Target: 663
• Locations: 1 country
• Sites: 1

Brief Summary

Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could improve overall survival. The purpose of this study is to compare the effects of chemotherapy alone using a combination regimen known as XELOX (capecitabine and oxaliplatin ) and selective use of the standard treatment to the standard treatment of chemotherapy and radiation.

Conditions

Rectal Neoplasms

Keywords

Neoadjuvant Chemotherapy; Preoperative radiotherapy; Chemoradiotherapy; Capecitabine; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Local-regional failure-free survival

  the time interval between the date of randomization and the date of local or regional progression/relapse, or death, whichever occurred first.regional progression/relapse, or death, whichever occurred first.

  Up to 5 years

Secondary Outcomes (6)

• Disease free survival

  Up to 5 years

• Pathologic complete response and tumor regression grade

  Up to 18 weeks

• Pelvic R0 resection rate

  Up to 18 weeks

• Overall survival

  Up to 5 years

• Adverse event (AE) profiles

  Up to 5 years

Study Arms (2)

Chemotherapy

EXPERIMENTAL

Patients receive neoadjuvant chemotherapy comprising oxaliplatin 130mg/m² ivdrip over 2 hours on day 1,capecitabine 2000 mg/m² on days 1-14, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.Patients without disease progression undergo low-anterior resection (LAR) with total mesorectal excision (TME) and 4 cycles of XELOX ( oxaliplatin 130mg/m² day 1，capecitabine 2000mg/m² days 1-14, repeated every 21 days). Patients with disease progression undergo chemoradiation as in group chemoradiotherapy before proceeding to LAR with TME.

Drug: Oxaliplatin; Drug: capecitabine

Chemoradiotherapy

EXPERIMENTAL

Patients receive capecitabine 825 mg/m² twice daily concurrently with radiation therapy for 5 days per week. Patients also undergo intensity-modulated radiation therapy 5 days a week for approximately 5.5 weeks. Patients then undergo LAR with TME and 4 cycles of XELOX ( oxaliplatin 130mg/m² day 1，capecitabine 2000mg/m² days 1-14, repeated every 21 days) .

Drug: capecitabine; Radiation: Radiation

Interventions

Oxaliplatin DRUG

130 mg/m² iv drip over 2 hours on day 1, repeated every 21 days.

Also known as: Eloxatin

Chemotherapy

capecitabine DRUG

825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week. 1000 mg/m² po twice daily on days 1- 14 repeated every 21 days in Group A and adjuvant chemotherapy in Group B.

Also known as: Xeloda

Chemoradiotherapy; Chemotherapy

Radiation RADIATION

The total dosage was 46Gy consisted of 23 fractions of 2 Gy to clinical target volume without a boost dose and with the boost 4 Gy consisted of 2 fractions of 2 Gy to gross tumor volume by IMRT or 3D-CRT.

Also known as: radiotherapy

Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DISEASE CHARACTERISTICS:
• Diagnosis of rectal adenocarcinoma
• Radiologically measurable or clinically evaluable disease
• Tumor location within 12cm from anal verge
• Clinical stage T2N+ or T3-4aNany,M0 Clinical staging should be estimated based on the combination of the following assessments: physical examination by the primary surgeon, CT scan of the chest/abdomen/pelvis, and a pelvic MRI with or without an endorectal ultrasound (ERUS)
• No evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on pre-operative MRI
• No tumor causing symptomatic bowel obstruction
• No distant metastasis
• PATIENT CHARACTERISTICS:
• ECOG performance status 0, 1
• White Blood Cell (WBC) ≥ 4,000/mm³
• Platelets ≥ 100,000/mm³
• Hemoglobin \> 10.0 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 1.5 times ULN

You may not qualify if:

• Pregnant or nursing
• Patient of child-bearing potential is not willing to employ adequate contraception
• Not willing to return to enrolling medical site for all study assessments
• With other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix
• Chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is ≥ 5 years)
• Prior pelvic radiation

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Shantou Central Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Fujian Cancer Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator
• Meizhou People's Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator
• Hubei Cancer Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• Longyan City First Hospital: collaborator
• Shengjing Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Jiangmen Central Hospital: collaborator
• West China Hospital: collaborator
• The Third Affiliated Hospital of Kunming Medical College.: collaborator

Study Sites (1)

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Mei WJ, Wang XZ, Li YF, Sun YM, Yang CK, Lin JZ, Wu ZG, Zhang R, Wang W, Li Y, Zhuang YZ, Lei J, Wan XB, Ren YK, Cheng Y, Li WL, Wang ZQ, Xu DB, Mo XW, Ju HX, Ye SW, Zhao JL, Zhang H, Gao YH, Zeng ZF, Xiao WW, Zhang XP, Zhang X, Xie E, Feng YF, Tang JH, Wu XJ, Chen G, Li LR, Lu ZH, Wan DS, Bei JX, Pan ZZ, Ding PR. Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial. Ann Surg. 2023 Apr 1;277(4):557-564. doi: 10.1097/SLA.0000000000005780. Epub 2022 Dec 20.

  PMID: 36538627 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Oxaliplatin; Capecitabine; Radiation; Radiotherapy

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)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Physical Phenomena; Therapeutics

Study Officials

• Peirong Ding, MD, Ph D

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: November 11, 2014
• Study Start: August 13, 2014
• Primary Completion: March 17, 2021
• Study Completion: March 1, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

CN (1)