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CRCPhase 3NCT01308086

Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer

A Phase 3 study testing 5-Fluorouracil, Leucovorin and Oxaliplatin in people with CRC, run by Hellenic Oncology Research Group at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to compare whether a 3-month treatment is at least not inferior to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of RFS in patients with high risk stage II or stage III radically resected colon cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CRC
What is being tested?
5-Fluorouracil, Leucovorin and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteGreece
Study dates
Oct 2010to Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically- - confirmed adenocarcinoma of the colon or rectum stage III or stage with at least one of the follow characteristics T4 tumours, undifferentiated tumor grade >3, bowel obstruction or perforation, vascular or lymphatic or perineural invasion, <12 nodes examined, Stage IV.
  • Signed written informed consent
  • Randomization between 2 -8 weeks after curative surgery
  • Age >18 years
  • ECOG performance Status 0-1
  • Pretreatment CEA within UNL
Show all 9Show fewer
  • Post-menopausal women or women willing to accept the use of an effective contraception. Pre-menopausal women should have a negative pregnancy test within 72 hours prior to randomization
  • Men should also accept to use an effective contraception
  • R0 resections

Who cannot join

  • Evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc")
  • Evidence of other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
  • No pregnant or lactating women
  • Presence of clinically relevant cardiovascular disease
  • Presenc of medical history or current evidence of CNS disease
  • Presence of peripheral neuropathy ≤ grade 1 (CTCAE v. 3.0)
  • History of clinically relevant psychiatric disability, precluding informed consent

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • University Hospital of Crete, Dep of Medical Oncology

    Heraklion

Other trials in Greece

About this study

Official title: A Multicenter Trial Investigating the Duration of Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX Regimen for Patients With High Risk Stage II or Stage III Colon Cancer

The purpose of this study is to compare whether a 3-month treatment is at least not inferior to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of RFS in patients with high risk stage II or stage III radically resected colon cancer.

Read the detailed description

Six months of adjuvant chemotherapy with 5-FU and oxaliplatin for patients with stage III colon cancer is the world-wide standard of care, based on the MOSAIC and C-07 trials. However, it leads to significant cost, toxicity, and inconvenience. In particular, the onset of oxaliplatin induced cumulative dose-dependent neuropathies is a significant issue. The ability to maintain efficacy with a reduced duration of therapy would have clear advantage to patients, to providers, and to the health care system.

Multiple large trials in the 1990s demonstrated that the previous standard of 12 months of therapy could be reduced to 6 months. A single small trial with 5-FU alone demonstrated similar outcomes for 3 versus 6 months of therapy. Thus, it is proposed to definitively evaluate the non-inferiority of 3 months of oxaliplatin-based adjuvant chemotherapy versus the current standard of 6 months. The primary endpoint will be disease-free survival (DFS).

It is essential to have sufficient power to eliminate the possibility of clinically meaningful inferiority of 3 months of therapy: a huge number of patients will be necessary. Previous efforts and experience have conclusively demonstrated that in colon cancer, a single, global trial is impractical. Consequently, an international, prospective pooled analysis will be performed, gathering data of independent trials run in different countries, to answer the single primary hypothesis that 3 months of adjuvant therapy with FOLFOX/XELOX is non-inferior to the current standard of 6 months. Among six planned countries, the Greek intergroup will conduct one of these trials.

Conditions
CRC
Keywords
Cancer, colorectal cancer, adjuvant chemotherapy, capecitabine, oxaliplatin, 5 fluorouracil
Medical subject headings
Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-FluorouracilDrug

    Also called 5-FU

    5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 \& 2, q2w, for 12 cycles

  • LeucovorinDrug

    Leucovorin 200mg/m2 IV in 2 hours, days 1 \& 2, q2w, for 12 cycles

  • OxaliplatinDrug

    Also called LoHP

    Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 12 cycles

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 8 cycles

  • OxaliplatinDrug

    Also called LoHP

    Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 8 cycles

  • 5-FluorouracilDrug

    Also called 5-FU

    5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 \& 2, q2w, for 6 cycles

  • LeucovorinDrug

    Leucovorin 200mg/m2 IV in 2 hours, days 1 \& 2, q2w, for 6 cycles

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 4 cycles

  • OxaliplatinDrug

    Also called LoHP

    Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 4 cycles

  • OxaliplatinDrug

    Also called LoHP

    Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 6 cycles

Study groups in NCT01308086
Study groupRoleWhat they receive
FOLFOX 4 - 6months or XELOX -6monthsActive comparatorNot described
Receives: Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Capecitabine
FOLFOX4 -3months or XELOX -3monthsExperimentalNot described
Receives: Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse Free Survival

    Measured: 3-years

Secondary outcomes (2)

  1. Overall Survival

    Measured: 3-years

  2. Safety Profil according to NCI-CTAE v 3.0

    Percentage (%) of treatments delays and interaptions in each arm Percentage (%) of dose received versus planned dose in each arm

    Measured: q2w

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionNov 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01308086
Sponsor's protocol ID
CT/09.12
Status last verified
Aug 2017
First submitted
1 Mar 2011
Last updated
9 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.

    PubMed 36306483

  • Iveson TJ, Sobrero AF, Yoshino T, Souglakos I, Ou FS, Meyers JP, Shi Q, Grothey A, Saunders MP, Labianca R, Yamanaka T, Boukovinas I, Hollander NH, Galli F, Yamazaki K, Georgoulias V, Kerr R, Oki E, Lonardi S, Harkin A, Rosati G, Paul J. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer. J Clin Oncol. 2021 Feb 20;39(6):631-641. doi: 10.1200/JCO.20.01330. Epub 2021 Jan 13.

    PubMed 33439695

  • Souglakos J, Boukovinas I, Kakolyris S, Xynogalos S, Ziras N, Athanasiadis A, Androulakis N, Christopoulou A, Vaslamatzis M, Ardavanis A, Emmanouilides C, Bompolaki I, Kourousis C, Makrantonakis P, Christofyllakis C, Athanasiadis E, Kentepozidis N, Karampeazis A, Katopodi U, Anagnosopoulos A, Papadopoulos G, Prinarakis E, Kalisperi A, Mavroudis D, Georgoulias V. Three- versus six-month adjuvant FOLFOX or CAPOX for high-risk stage II and stage III colon cancer patients: the efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) project. Ann Oncol. 2019 Aug 1;30(8):1304-1310. doi: 10.1093/annonc/mdz193.

    PubMed 31228203

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-Fluorouracil, Leucovorin and Oxaliplatin in people with CRC, run by Hellenic Oncology Research Group at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse Free Survival (time frame: 3-years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308086, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.

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